SBSBN: Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT06063278
Collaborator
(none)
100
1
2
43.5
2.3

Study Details

Study Description

Brief Summary

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: l Group Therapy for BN.
N/A

Detailed Description

This is a controlled non randomized study that will compare a group of patients with BN that participate in the SBS group therapy with a group of BN patients who will be in wait list as a control condition.

Patients for this single center trial will be recruited from the outpatient facility of the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain).

After assessed for eligibility participants will be given a set of self -report questionnaires. After the questionnaires are completed participants will be allocated to wait list condition or to the treatment arm. Time between assessment and starting the SBS group will be a month or least. Participants will be administered the same questionnaires the following month after finishing the treatment or after 3 to 4 months after the first assessment for the control condition.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Actual Study Start Date :
May 6, 2022
Anticipated Primary Completion Date :
May 6, 2024
Anticipated Study Completion Date :
Dec 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BN Group

Patients will take part of a Therapeutic BN Group

Behavioral: l Group Therapy for BN.
9 to 10 group sessions of 90 to 120min each

No Intervention: Waiting List

Participants will be in the waiting list.

Outcome Measures

Primary Outcome Measures

  1. Eating Attitudes Test, E-40. [3 months]

    A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms.

  2. Eating Disorder Inventory, EDI [3 months]

    A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms

  3. Bulimic Investigatory Test Edinburgh, BITE [3 months]

    A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms

  4. Body Shape Questionnaire, BSQ-34 [3 months]

    A self report questionarie that assesses eating disorder symptomatology. The score is ranging between 34-204 points. Higher scores point to an increased level of concern on body shape.

Secondary Outcome Measures

  1. Working alliance Inventory -short, WAIS. [3 months]

    A self report questionarie that assesses bulimia nervosa symptomatology. Values range from 12 to 84. Hihger scores meaning higher therapeutic alliance.

  2. Autism-Spectrum Quotient, AQ [3 months]

    A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.

  3. Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q. [3 months]

    A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.

  4. Beck Depression Inventory, BDI-II [3 months]

    A self report questionarie that assesses depressive symptoatology. The range of scores is 0-83. Higher scores mean higher depressive symptoms.

  5. Rosenberg Self-Esteem Scale, RSE. [3 months]

    A self report questionarie that assesses self steem. The scale ranges from 0-30. Higher scores mean higher self-esteem. The range scores is 0-60.

  6. State -Trait Anxiety Inventory, STAI. [3 months]

    A self report questionarie that assesses anxiety. Higher scores mean higher anxiety.

  7. Difficulties in Emotion Regulation Scale (DERS). [3 months]

    A self report questionarie that assesses emotion regulation difficulties. The scale ranges from 28-40. H igher scores indicate more difficulty in emotion regulation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnostic of Bulimia Nervosa
Exclusion Criteria:
  • Not understanding Spanish or Catalan Language

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

Sponsors and Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT06063278
Other Study ID Numbers:
  • IIBSP-BUL-2021-144
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 2, 2023